The Association of Blood Haemoglobin and Colour of Gums

The Association of the Levels of Blood Haemoglobin to the Distribution and Severity of Gingival Melanin Pigmentation at 3 Different Periodontal Health Status

AIM:

To evaluate the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status

SAMPLE SIZE ESTIMATION

• Done using GPower v.3.1.9.2
• Total sample size = 60 (20 each in 3 groups)
• Effect size = 40%
• Power = 80%
• α-error = 5%

SAMPLING:

• Simple random sampling
• Subjects to be recruited from out patient pool of KLE Society's Institute of Dental Sciences, Bangalore

• Subjects to be categorised into 3 groups (20 subjects each)

  1. Group A - Healthy periodontium
  2. Group B - Gingivitis
  3. Group C - Periodontitis

PARAMETERS ASSESSED

• Blood Haemoglobin Concentration (in %gm/dL)
• Hedin Melanin Index Score 0: No pigmentation Score 1: one or two solitary unit(s) of pigmentation in papillary gingiva without formation of a continuous ribbon between solitary units Score 2: More than three units of pigmentation in papillary gingiva without the formation of a continuous ribbons of pigmentation Score 3: One or more short continuous ribbons of pigmentation Score 4: One continuous ribbon including the entire area between canines

STATISTICAL ANALYSIS

• SPSS for Windows Version 22.0 to be used
• Descriptive statistics: It includes expression of study parameters in terms of Mean & SD for continuous variables, whereas in terms of frequency and proportions for categorical variables.
• Inferential Statistics:

Chi Square Test will be used to compare the pigmentation index between 03 groups. And similarly, gender wise comparison of hemoglobin concentration will be done using the same test.

One-way ANOVA test followed by Tukey's HSD post hoc Analysis will be used to compare the mean hemoglobin levels based on the pigmentation index scores in each group.

The level of significance [P-Value] was set at P<0.05

Study Overview

• Status: Unknown
• Conditions: Healthy; Periodontitis; Gingivitis; Gingival Pigmentation
• Intervention / Treatment: Other: Blood Haemoglobin

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects to be recruited from out patient pool of KLE Society's Institute of Dental Sciences, Bangalore, India

Description

Inclusion Criteria:

• Systemically healthy individuals

• Absence of pathological gingival pigmentation

  1. Group A - Healthy Periodontium: Absence of clinical signs of inflammation like bleeding on probing, erythema, edema, attachment loss, bone loss, patient symptoms, (bone levels at 1-3mm apical to CEJ)
  2. Group B - Gingivitis: Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,
  3. Group C - Periodontitis: Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,periodontal pocketing, clinical attachment loss, radiographically assessed bone loss

Exclusion Criteria:

• Tobacco associated pigmentation - smoker's melanosis, chewing/ pouching tobacco
• Pigmentation from exogenous pigments - amalgam tattoo, cultural tattooing, beverages, food colours, betelnut/khat chewing, heavy metals ( mercury, silver, arsenic, bismuth, graphite, lead), topical medications, other foreign bodies
• Pigmentation from endogenous pigments - jaundice, ecchymosis/ petechiae, haemochromatosis, hemosiderin
• Long term consumption of pigmentation causing drugs - ACTH, antimalarial drugs, busulfan, doxorubicin, minocycline, oral contraceptives, phenothiazies
• Syndromes and systemic diseases associated with pigmentation - Addison's disease. Albright's syndrome, basila melanosis, β-thalassemia, healed / healing mucocutaneous lesions, hereditary hemorrhagic Telangiectasia, HIV-associated melanosis, Neurofibromatosis, Peutz Jeghers syndrome, hamartoma, pyogenic granuloma, epulis
• Benign or malignant lesions involving gingival - angiosarcoma, hemangioma, Kaposi's sarcoma, malignant melanoma, melanocytic nevus, pigmented vaculoe

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A - Healthy Periodontium; Absence of clinical signs of inflammation like bleeding on probing, erythema, edema, attachment loss, bone loss, patient symptoms, (bone levels at 1-3mm apical to CEJ) n=20	Other: Blood Haemoglobin; Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood
Group B - Gingivitis; Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla, n=20	Other: Blood Haemoglobin; Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood
Group C - Periodontitis; Presence of cardinal signs of inflammation along with, bleeding and discomfort on gentle probing, loss of knife-edged margin and blunting of papilla,periodontal pocketing, clinical attachment loss, radiographically assessed bone loss n=20	Other: Blood Haemoglobin; Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Haemoglobin to Melanin pigmentation	To assess the association of the levels of blood haemoglobin to the distribution and severity of gingival melanin pigmentation at 3 different periodontal health status by Hedin Melanin Index both by intragroup comparison within each of the 3 groups and intergroup comparison between the three groups	Baseline

Collaborators and Investigators

• Sponsor: KLE Society's Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: December 30, 2018
• First Submitted That Met QC Criteria: December 30, 2018
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontitis; Gingivitis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: riya2pigmentation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No